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Advisor
Posts: 41
Registered: ‎05-17-2016
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Accepted Solution

Required ACPH

What is the required ACPH in an ante room? USP <797>  reads :

 

An ISO Class 7 (see Table 1) buffer area and ante-area supplied with HEPA-filtered air shall receive an ACPH of not less than 30

 

Does this mean an ISO 7 buffer and ISO 7 or 8 ante? So if I have an ISO class 8 ante room, should my room have a minimum of 30 ACPH?

 

Expert
Posts: 1,142
Registered: ‎02-23-2010
0

Re: Required ACPH

Erika,

 

Unfortunately, USP 797 failed to specify the ACPH in the ISO Class 8 anteroom.  The FDA Aseptic Processing Guidance stipulates a minimum of 20 ACPH.  Remember you have an excellent set of references from the CriticalPoint Sterile Compounding Boot Camp.  Our team is recommending 60 ACPH for an ISO Class 7 anteroom to ensure that a "state of control" can be maintained. If you can get 30 ACPH for an ISO Class 8 anteroom that would be great.  

Eric S. Kastango, MBA, RPh, FASHP

It's all about the patient.